Body SAR will be required for Japan starting April 1, 2014. The limit is 2 W/kg for body and 4 W/kg for arms and legs. The SAR is calculated over any 10g of tissue (as compared to 1g of tissue for FCC). Body SAR will be exempt for radio devices that have less than 20mW output power. The test method, for the most part, is harmonized with IEC 62209-2. Read about SAR requirements in North America and Europe.
There is a second FCC Notice of Proposed Rulemaking (NPRM) coming out early next year proposing still-unknown new certification procedures for FCC. This is in addition to the first NPRM that issued in February 2013 and which included significant changes to the FCC equipment authorization process. FCC is calling it a “complete overhaul of the certification process.” It is expected these changes will take effect in late 2014.
Mexico and Israel MRAs
Mexico and Israel Mutual Recognition Agreements (MRAs) should be finalized late next year. When Phase I of the MRAs are implemented, U.S. manufacturers will be able to perform testing at a local U.S. lab for those countries. Later, when Phase II is implemented each country will be able to certify products for the other.
For questions about these changes or for an immediate test need, visit our Quote Center.
Register now for MET’s free EMC & Wireless Design & Testing Seminar in Baltimore next week.
Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical
devices. The guidance is recommended, but not mandatory.
FDA said its recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals and clinical laboratories.
The guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including electromagnetic compatibility (EMC).
The use and deployment of RF wireless technology in and around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might contain many sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another, the agency said.
FDA says these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products.
FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. Beyond FCC requirements, FDA recommends using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.
IEC 60601-1-2 is a FDA-recognized consensus standard for EMC, but it does not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device’s wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.
EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).
FDA worked closely with the Federal Communications Commission (FCC) to develop this guidance.
MET Labs teamed with FDA on a voluntary Program to Test Medical Devices for RFID Interference. Find out more about the Program.
MET’s Annual Global Compliance Seminar in September will include a session on Electrical Medical Equipment Approvals for EU. Register here.
The U.S. Federal Communications Commission (FCC) has proposed important changes to its equipment testing and authorization program under Part 15 and Part 68 of its rules. The FCC says the changes will streamline the approval process and expedite the introduction of new devices to the market.
In a Notice of Proposed Rulemaking issued last month, the FCC proposed a number of changes to its existing equipment authorization program. The key proposed changes include:
TCB Accreditation – Telecommunications certification bodies (TCBs) – like MET Labs – will be accredited in accordance with the requirements of ISO/IEC 17011 and ISO/IEC 17065. These standards replace ISO/IEC Guides 58, 61 and 65.
Testing Laboratories Accreditation – Laboratories that test equipment subject to certification or approval under any of its rules must be accredited to ISO/IEC 17025.
TCB Authority – The FCC will no longer directly issue any grants of equipment authorization. Instead, TCBs will authorize and deny all products subject to certification.
Post-Market Surveillance – For post-market surveillance, the FCC will specify the number and types of samples that a TCB must test.
Assessing TCB Performance – NIST will assess TCB performance. The Commission also outlined a process to address TCB non-performance issues.
Measurement Procedures – ANSI C63.10-2009 will be the procedure used to determine the compliance of intentional radiators, and ANSI C63.4-2009 will be the procedure for assessing unintentional radiators.
We understand these proposed changes are likely to go through without significant modification, but first there is a comment period to elicit feedback. Comments on the Commission’s proposed rule changes are due by late March here.
Read the complete text of the FCC’s Notice of Proposed Rulemaking regarding important changes to its equipment testing and authorization program under Part 15 and Part 68.
MET Labs is an accredited testing laboratory and TCB. Contact us for FCC Testing or Certification assistance.
In June, the Federal Communications Commission (FCC) announced it would review its rules on radiation exposure from cell phones. The FCC’s current Specific Absorption Rate (SAR) limits were set fifteen years ago, in 1996.
Any day now, the FCC is expected to publish a Notice of Inquiry, which will be open to public comment for a couple months. After that, the commission may issue some proposed rules. After another comment period, the FCC could issue a final rule.
It is unlikely there will be a change to the SAR regulations. The last time the FCC proposed a change to its RF rules was in 2003, and these minor-change amendments are still pending.
The FCC’s current SAR limits are already the tightest in the world. SAR is the rate at which your body absorbs energy from a radio-frequency magnetic field. It’s measured in watts per kilogram or W/kg. To be considered safe, every cell phone model sold in the U.S. must adhere to a SAR that’s less than 1.6 watts per kilogram taken over a volume containing a mass of 1 gram of tissue, even under the worst conditions.
The likely reason for the review of the cell phone radiation exposure rules now? The Government Accountability Office (GAO) has been looking into the adequacy of the cell phone standard, and the FCC wants to be seen as proactive in this area.
Read about MET’s SAR Testing capabilities.
The U.S. Federal Communications Commission (FCC) has issued draft revisions to six Knowledge Database (KDB) publications for RF exposure and SAR compliance.
KDB Publication 447498 – General RF Exposure Policies for Equipment Authorization
KDB Publication 941225 – SAR Evaluation Considerations for LTE Devices
KDB Publication 865664 – SAR Measurement Requirements, Compliance Reporting and Documentation for 100 MHz – 6 GHz
KDB Publication 616217 – SAR Evaluation Considerations for Laptop, Notebook, Netbook and Tablet Computers
KDB Publication 648474 – SAR Evaluation Considerations for Handsets with Multiple Transmitters and Antennas
KDB Publication 643646 – RF Exposure Evaluation Considerations for Occupational Push-to-Talk Two-Way Radios
The public may post a comment on these proposed revisions through June 1, 2012.
Other RF Exposure KDBs
Remaining RF exposure KDB publications that do not have draft revisions are:
- KDB Publication 248227 – Additional SAR Measurement Procedures that Specifically Address 802.11 a/b/g Devices
- KDB Publication 615223 – SAR Requirements and Procedures for 802.16e/WiMax Devices
- KDB Publication 450824 – SAR Probe Calibration and System Verification Considerations for Measurements from 150 MHz to 3 GHz
- KDB Publication 680106 – Rules Regulating Short Distance Wireless Inductive Coupled Charging Pads or Charging Devices
Questions about SAR compliance? A SAR testing expert will be available next week at 2012 International CTIA Wireless at the MET Labs exhibit.
The recent delay in the high-profile new product launch of the Raspberry Pi has reminded electronics manufacturers of a simple truth: Compliance sometimes means exceeding regulatory requirements due to buyer demands.
The iPhone-size Pi is a $25 mini PC that is intended to teach students about programming. Its maker, the UK-based Raspberry Pi Foundation, had been operating under the assumption that this type of engineering sample product could be sold in the UK without a CE mark. After all, the rival ARM-based Beagleboard development kit is sold under the same terms without a CE mark, as are the majority of similar prototyping platforms.
The rub here is that the Pi has proved wildly popular, making its distributors nervous about lawsuits. Distribution partners element14/PremierFarnell and RS Components insisted that the device receive a CE mark to indicate compliance with electronic emissions guidelines. Their judgment was seconded by the UK Department for Business, Innovation and Skills (BIS), which said the Pi did in fact need to carry the CE marking.
Last week, to everyone’s relief, the Pi passed EMC testing without requiring any hardware modifications. The testing was conducted at Panasonic’s facility in South Wales.
The device passed radiated and conducted emissions and immunity tests in a variety of configurations, as well as electrostatic discharge (ESD) testing. In the lab for all of last week, the Pi is now also reportedly compliant with requirements for United States’ FCC, Australia’s C-Tick, and Canada’s Technical Acceptance Certificate.
Find out more about testing requirements and cost and lead time for CE Marking.
In follow up to our post on product safety web links, here are the Internet resources we use to keep current with electromagnetic compatibility (EMC) regulations and industry happenings.
What are we missing? Leave a comment with a link to it.
STANDARDS & REGULATORY
FCC OET Federal Communications Commission Office of Engineering and Technology for compliance with Title 47 of the Code of Federal Regulations.
U.S. Military Standards The Department of Defense Single Stock Point for Military Specifications, Standards and Related Publications (DODSSP) is the official source of DoD specifications and standards.
FDA Electromagnetic Compatibility U.S. Food and Drug Administration standards and regulations for radiation-emitting medical products.
ANSI American National Standards Institute is the voice of the U.S. standards and conformity assessment system.
Verizon NEBS The telecom leader in Network Equipment Building Systems requirements.
Industry Canada Oversees Radio, Spectrum and Telecommunications regulations for Canada.
Health Canada Electromedical Standards Canada’s version of FDA.
CENELEC The European Committee for Electrotechnical Standardization. It creates voluntary European electrotechnical standards (ENs).
UK Defence Standardization UK Defence Standards – registration required.
NPL Electromagnetics UK National Physical Laboratory Electromagnetics division.
GOST Russia Federal Agency on Technical Regulating and Metrology.
AFNOR French National Standards Institute.
AENOR Spanish National Standards Institute.
SFS Finnish Standards Association.
CNCA Regulations of the People’s Republic of China on Certification and Accreditation and Applying China Compulsory Certification (CCC) Mark.
RRA National Radio Research Agency, Korea’s regulatory agency for KC Mark.
BSMI Bureau of Standards, Metrology & Inspection is the authority responsible for standardization, metrology and product inspection in Taiwan.
VCCI Council Japanese EMC regulation and certification.
ACMA Australia EMC Compliance and Labeling.
New Zealand Ministry of Economic Development Radio Spectrum Division.
CB Scheme The international certification program managed by the IECEE, with over 60 countries participating.
IEC CISPR The International Electrotechnical Commission International Special Committee on Radio Interference.
Ecma EMC & EMF Ecma International is dedicated to the standardization of Information and Communication Technology (ICT) and Consumer Electronics (CE).
ISO International Organization for Standardization is the world’s largest developer and publisher of International Standards.
IEEE-SA IEEE Standards Association.
SAE International Standards for aerospace, automotive, and commercial vehicles.
ETSI The European Telecommunications Standards Institute (ETSI) produces global standards for Information and Communications Technologies (ICT).
RTCA SC-135 Produces the international de facto standard (RTCA/DO-160) for environmental testing of commercial avionics.
ITU International Telecommunication Union is the United Nations specialized agency for Information and Communication Technologies (ICT).
NIST Directory of Electromagnetic Compatibility & Telecommunications Laboratories
IHS Standards Has a wide variety of standards available for purchase.
EU Directives Includes link to harmonized standards references.
PUBLISHERS: MAGAZINES & BLOGS
Interference Technology Trade publication dedicated to EMC/EMI issues.
EMC Journal UK-based bimonthly publication.
IN Compliance Magazine Covers EMC along with other compliance disciplines.
Evaluation Engineering Magazine includes coverage of environmental simulation and EMI.
Test & Measurement World Covers EMC occasionally.
Electromagnetic News Report U.S.-based bimonthly publication.
Certification & Test Blog Information, from TRaC Global, on testing and certification services, ranging from telecoms & radio and environmental, through to analysis, safety and EMC.
Directive Decoder Blog Analysis of European legislation.
NEMA Currents Blog From the Association of Electrical and Medical Imaging Equipment Manufacturers.
IEEE EMC Society The world’s largest organization dedicated to the development and distribution of information, tools and techniques for reducing electromagnetic interference.
Electrostatic Discharge Association A professional voluntary association dedicated to advancing the theory and practice of electrostatic discharge (ESD) avoidance.
Electrostatics Society of America A nonprofit professional society devoted to the advancement and improved understanding of electrostatics.
EMCIA The Electromagnetic Compatibility Industry Association is a UK association for companies and organizations which have a vested interest in EMC and associated European directives.
EMC Test Labs Association UK group that works to ensure a commonality of approach to EMC testing.
EMC Society of Australia A technical society of the Institution of Engineers Australia. The Society operates to promote the science and practice of electromagnetic compatibility in Australia.
PSES Email Forum Listserv made up of about 700 product safety and EMC engineers and technicians. Sponsored by IEEE.
Testing Equipment Suppliers Published by IECEE.
iNARTE Certifies qualified engineers and technicians in the fields of Telecommunications, EMC/EMI, Product Safety, ESD and Wireless Systems Installation.
What are your favorite online EMC/EMI compliance resources? Please leave a comment with a link to it.
Need testing? Get EMC testing cost and lead time here.
Last week, MET Labs attended the FCC Telecommunication Certification Body (TCB) Council TCB Workshop in Baltimore. Here was the agenda.
One of the workshop’s more interesting presentations was on the R&TTE Directive. Following is a summary of the key points.
The Radio and Telecommunication Terminal Equipment Directive applies in Europe and the European Economic Area.
There is no certification for the R&TTE Directive 1999/5/EC. Meeting the requirements is the responsibility of the manufacturer or whoever puts the device on the market.
- Products must have CE mark to show compliance
- Declaration of Conformity (DoC) must be created for each device
- Technical Construction File (TCF) is necessary to demonstrate compliance
The CE mark must be visible on the label, user manual, and packaging, and must include the Notified Body and Alert Symbol, if applicable.
The DoC must be available in each language, and must be traceable to a signatory.
The TCF must be kept for at least 10 years after the final version of each device has been made.
R&TTE Directive does not give test limits. It instructs the manufacturer that the device must comply with certain performance requirements:
- Article 3.1a – Health (RF exposure; boundary calculations; acoustic safety; typical operation)
- Article 3.1a – Safety (EN 60950 for IT equipment; EN 60065 for Audio/Video equipment)
- Article 3.1b – EMC Performance (EN 301 489 series for radio; EN 55022 & EN 55024 for TTE)
- Article 3.2 – Radio Spectrum (output power; frequency tolerance; spurious emissions; receiver performance tests; tests at extreme voltage/temperature)
R&TTE Directive divides products into two classes:
- Class 1 – No restrictions on putting the device into service
- Class 2 – Restrictions exist for use of the device, and Country Notifications may be necessary
Ideally, all devices fall within an existing harmonized (harmonised) test standard. If you test to a harmonized standard and pass, there is a presumption of conformity to the essential technical requirements.
Harmonized standards are listed by the European Commission in its Official Journal (OJ).
When a standard is superseded, the device should meet the new version of the standard to stay compliant. There is an overlap period.
A Notified Body opinion is required if harmonized standards are not fully applied in these situations:
- Device has new technology with no applicable standards yet
- New standards are not yet harmonized
- Family of products, where the standard has not been applied to some models
- Test procedures or processes of the harmonized standard were not followed
If the technology is new and no harmonized standards exist, the manufacturer works with a Notified Body – like MET Laboratories – to determine a test plan, or parts of another standard to use. Alternatively, use a new version of a standard which has not yet become harmonized.
For most Radio and Telecommunication Terminal devices, the R&TTE Directive alone is sufficient – the EMC and Safety (Low Voltage) Directives do not apply.
R&TTE Directive was written in 1999. The new version of the directive is being written now, with these goals in mind:
- Improve traceability to DoC signatory
- Improve compliance rates
- Improve process for dealing with non-compliant products
- Maintain equipment quality
- Maintain trade
The next TCB event is a FCC/TCB Conference Call on December 13. The call is restricted to TCB personnel, but Associate Members can receive the call minutes.
Find out more about compliance with the R&TTE Directive.
Effective November 1, 2011, the Administrative Council for Terminal Attachments (ACTA) is allowing Responsible Parties to validate their Part 68 Telephone Terminal Equipment (TTE) Responsible Party Code (RPC) data for the 2012 calendar year. A discounted rate will be in effect through January 31, 2012.
RPC data is required to be validated on an annual basis. The RPC establishes the connection between the responsible party and the telephone equipment stored in the database, and is used by the Federal Communications Commission (FCC) and U.S. Customs.
Responsible Party Codes that are updated will be noted by a “label” to show that the RPC data have been validated and are accurate. On at least an annual basis, ACTA provides the FCC with reports detailing those responsible parties who have, and have not, validated their data.
See ACTA’s announcement.
Find out more about 47 CFR Part 68 Telephone Terminal Equipment certification and validation.
There was much relief when the European Union postponed the cessation of EN 55022:1998 to October 1, 2011. But now Information Technology Equipment manufacturers selling ITE products in the EU must face the music – EN 55022:2006 is upon us, as is Amendment A1:2007.
Here is a basic primer on the changes:
EN55022:2006 is based on CISPR 22 Edition 5, released in 2005. The major change in this edition was to remove the requirement for ferrite clamps to be used on cables exiting the test site.
Amendment A1 was issued by CISPR in 2005 also, and added requirements for testing above 1 GHz. The EN version was released in 2007.
Testing above 1 GHz is designed to simulate a free-space environment, so the ground plane needs to be covered with rf-absorbing material to suppress reflections. In addition, the specifications require a very low reflection from around the EUT.
The CISPR 22/EN 55022 limits are 4dB lower than the U.S. FCC limits for measurements below 3GHz and identical above 3GHz.
As with FCC rules, the upper frequency of the measurement range for the CISPR 22/EN 55022 measurements is a function of the highest frequency generated within the product.
Results from tests conducted per the older versions can likely continue to be used in October 2011 to help support your Declaration of Conformity to the EMC or R&TTE Directives. To see what tests may need to be repeated, we need to look at each of the different tests in turn:
AC power port conducted emissions, 0.15-30 MHz
Telecommunications ports conducted emissions
New ISN specification should produce a lower measurement, so there is not likely to be an impact here.
Radiated emissions, 30-1,000 MHz
Re-evaluation without the ferrite clamps is required, as it could cause an increase in the levels of radiated emissions, primarily for emissions radiated by the interface cables to the remote equipment.
Radiated emissions above 1GHz
This is a new requirement for equipment with internally-generated frequencies above 108 MHz.
For a more technical discussion of the new requirements of EN 55022:2006+A1:2007, watch this recorded webinar.